To study the effect of WF Fiber on insulin resistance and (continuous) glucose metabolism and potential underlying mechanisms, body weight and waist circumference, microbiota composition and fasting GLP1/PYY/SCFA, in subjects with pre-diabetes.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in fasting insulin and HOMA-ir (a markers of insulin resistance) are
the primary outcomes of the study.
Secondary outcome
Changes in mean glucose and glycemic variability (CGM), body weight, waist
circumference, microbiota composition, breath hydrogen and GLP-1/PYY and SCFA
are the secondary outcomes.
Background summary
Dietary fiber is usually lower than recommended and dried vegetable can be a
useful additional source. This may improve glucose metabolism by changes in
microbiota composition.
Study objective
To study the effect of WF Fiber on insulin resistance and (continuous) glucose
metabolism and potential underlying mechanisms, body weight and waist
circumference, microbiota composition and fasting GLP1/PYY/SCFA, in subjects
with pre-diabetes.
Study design
Single-blind randomized controlled parallel study.
Intervention
One group receives daily a dose of 30g of WholeFiber (WF fiber) and the other
group 16g maltodextrin (placebo) for 21 days. Before that time a 2 week run-in
on half the dose wil take place.
Study burden and risks
The intervention is therapeutic to the participant of the intervention group,
and non-therpaeutic to the control group. The risk associated with the
participation is negligible and the burden can be considered as minimal. At
screening the following measurements and questionnaires will be taken:
inclusion and diabetes risk score questionnaire (1x), food frequency
questionnaire for dietary fiber (1x), height (1x), weight (1x), fasting blood
glucose (finger prick) and a breath sample for H2 (1x). During the intervention
period over 3 weeks, with an additional 2 week run-in period and a 2 week
wash-out period, subjects will take dietary supplements on the morning of each
day of the intervention period, and come to the university on 3 occasions.
During this 7 week period the following measurements will be taken: body weight
(3x), fasting blood sample (2x), fasting breath sample (2x), continuous glucose
monitoring (28 days), faecal samples (4x), well-being diary (49 days).
Stippeneng 4
Wageningen 6700 AA
NL
Stippeneng 4
Wageningen 6700 AA
NL
Listed location countries
Age
Inclusion criteria
* Male/Female
* Age 40-75 yr
* Fasting blood glucose between 5.6 and 6.9 mmol/L (pre-diabetes according to American Diabetes Association 2016)
* Or fasting blood glucose between 5.0 and 5.6 mmol/L and diabetes risk score (DRS) * 9.
Exclusion criteria
* Having a history of medical or surgical events that may significantly affect the study outcome (IBS or IBD)
* Having Diabetes
* Medical drug use: for diabetes
* Medical drug use: antibiotic use within 3 months of the study start or chronic use of antacids
* Mental status that is incompatible with the proper conduct of the study
* Reported unexplained weight loss or weight gain of > 5 kg in the month prior to pre-study screening
* Reported slimming or medically prescribed diet
* Reported vegetarian, vegan or macrobiotic life-style
* Consumption of pre-probiotics or fibre supplements
* Sensitive to medical skin adhesives;* Recent blood donation (<1 month prior to Day 01 of the study)
* Not willing or afraid to give up blood donation during the study
* Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
* Current participation in other research from the Division of Human Nutrition
* Not having a general practitioner
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63551.081.17 |